CN105288836B - Cladding molding including anchoring device and identification division enters port - Google Patents

Cladding molding including anchoring device and identification division enters port Download PDF

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Publication number
CN105288836B
CN105288836B CN201510645219.1A CN201510645219A CN105288836B CN 105288836 B CN105288836 B CN 105288836B CN 201510645219 A CN201510645219 A CN 201510645219A CN 105288836 B CN105288836 B CN 105288836B
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CN
China
Prior art keywords
port
flange
ontology
inject
power
Prior art date
Application number
CN201510645219.1A
Other languages
Chinese (zh)
Other versions
CN105288836A (en
Inventor
M·威利
J·L·诺伊斯
D·M·西斯
W·R·巴伦
K·J·克里斯琴
A·欧罗密
Original Assignee
C·R·巴德股份有限公司
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
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Publication date
Priority to US26212609P priority Critical
Priority to US61/262,126 priority
Application filed by C·R·巴德股份有限公司 filed Critical C·R·巴德股份有限公司
Priority to CN201080051911.7A priority patent/CN102612343B/en
Publication of CN105288836A publication Critical patent/CN105288836A/en
Application granted granted Critical
Publication of CN105288836B publication Critical patent/CN105288836B/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/02Access sites
    • A61M39/0208Subcutaneous access sites for injecting or removing fluids
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M2039/0009Assemblies therefor designed for particular applications, e.g. contrast or saline injection, suction or irrigation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M2039/0036Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use characterised by a septum having particular features, e.g. having venting channels or being made from antimicrobial or self-lubricating elastomer
    • A61M2039/0081Means for facilitating introduction of a needle in the septum, e.g. guides, special construction of septum
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/02Access sites
    • A61M2039/0205Access sites for injecting media
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/02Access sites
    • A61M39/0208Subcutaneous access sites for injecting or removing fluids
    • A61M2039/0223Subcutaneous access sites for injecting or removing fluids having means for anchoring the subcutaneous access site
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/02Access sites
    • A61M39/0208Subcutaneous access sites for injecting or removing fluids
    • A61M2039/0238Subcutaneous access sites for injecting or removing fluids having means for locating the implanted device to insure proper injection, e.g. radio-emitter, protuberances, radio-opaque markers
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10TTECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T29/00Metal working
    • Y10T29/49Method of mechanical manufacture
    • Y10T29/49826Assembling or joining

Abstract

A kind of entrance port of the cladding molding including anchoring device and identification division.Disclose a kind of entrance port that power can inject.In one embodiment, the port that enters that the power can inject includes:Ontology, the ontology are defined through the enterable fluid cavity of spacer;Continuous annular flange, the spacer is limited in the top of the ontology of the fluid cavity nearside by the continuous annular flange, the flange is formed by radiopaque material, the flange includes one or more identification divisions, and one or more identification division conveys what the power can inject can be injected into port into action edge to user;And biddability outer outlet body, the biddability outer outlet body be set around the ontology and with the Hp contacts.

Description

Cladding molding including anchoring device and identification division enters port

The application be submit on November 1st, 2010 application No. is 201080051911.7, entitled " including anchoring The divisional application of the application for a patent for invention of the entrance port of the cladding molding of device and identification division ".

Cross reference to related applications:This application claims on November 17th, 2009 it is submitting, entitled " including anchoring mark Partial implantable cladding molding enters port (Implantable Overmolded Access Port Including Anchoring Identification Feature) " U.S. Provisional Patent Application No.61/262,126 priority, should Application is integrally incorporated herein by reference.

Technical field

The application generally relates to the entrance port that power can inject.

Invention content

Brief overview, embodiment of the present invention are related to entering port to what patient subcutaneously entered for providing.Specifically, In one embodiment, be implanted patient's body into port, then with the conduit stream that has been inserted into patient's vascular system Connect to body.Through such placement and configuration, can be accessed percutaneously into port by needle or other infusion/suction units, from And by port and catheter drug delivery to patient's vascular system, or from patient's vascular system suction blood or other fluids.

In one embodiment, port includes the inside body for being defined through the enterable fluid cavity of spacer.Including Biddability (compliant) outer outlet body of organosilicon is set around at least part of the ontology.Flange and the port sheet Body is included together and is covered by the outer outlet body.Periphery of the flange around the port body of the neighbouring spacer Radially, thus described in being prevented in the case of for example deviateing (miss) described spacer when needle seeks entry into the port Needle penetrates the substantive distance of the outer outlet body one.

In one embodiment, can also include both anchoring device and identification division, institute into the flange of port Anchoring device is stated for the outer outlet body to be fixed to the port body, the identification division is by X-ray imaging technique It is visible, for conveying the information of at least one attribute into port to indicate.The outer outlet body is also provided using anti-micro- The suitable surface of biology/antithrombus formation coating.

The present invention discloses a kind of entrance port that is used to provide and subcutaneously enter to patient, described to include into port:Ontology, The ontology is defined through the enterable fluid cavity of spacer;Biddability outer outlet body, the biddability outer outlet body is around the ontology At least part setting;And flange, the flange covered by the outer outlet body and from the ontology extend, when needle by with Come when penetrating the spacer, the flange prevents the needle from passing through the flange in the outer outlet body.

Wherein, the flange around the ontology periphery radially, and the wherein described flange further include for will The outer outlet body is fixed to the anchoring device of the ontology.

Wherein, the outer outlet body is overmolded on the body, is approximately reached the spacer fixed to described At the maintenance ring of ontology, and the wherein described anchoring device includes the multiple holes for being defined through the flange.

Wherein, the outer outlet body includes organosilicon, wherein the flange includes titanium, and the wherein described hole is defined to shape At alphanumeric character.

Wherein, the ontology includes by outer outlet body covering, the anchor for the outer outlet body to be fixed to the ontology Determine device, the anchoring device includes one in the multiple teeth extended from the ontology and multiple dovetail convex extension parts.

Wherein, the outer outlet body includes at least one of antimicrobial components and antithrombus formation component.

The present invention discloses a kind of entrance port that is used to provide and subcutaneously enter to patient, described to include into port:Ontology, The ontology is defined through the enterable fluid cavity of spacer;Biddability outer outlet body, the biddability outer outlet body is around the ontology At least part setting;And flange, the flange are covered by the outer outlet body and from described in the neighbouring spacers Ontology extends, the flange include by the visible identification division of X-ray imaging technique, the identification division convey it is described into The information of at least one attribute of inbound port indicates.

Wherein, the flange around the ontology periphery extend, wherein the identification division include multiple alphanumerics or Significant character, and the wherein described identification division indicates described to inject into action edge into port.

Wherein, the identification division includes at least one hole for being defined through the flange, thus as will be described outer Cover body is fixed to the anchoring device of the ontology.

Wherein, the ontology includes metal material and the wherein described flange is integrally formed with the ontology.

Wherein, the flange and the ontology are separately manufactured, wherein the flange includes multiple key-shaped recesses, it is each described Key-shaped recess is assembled on the corresponding key-shaped tongue on the ontology into port, and the wherein described tongue is in the flange Recess is deformed in this way after being placed on the tongue, so that the flange is by the ontology maintenance.

Wherein, the ontology of the port includes acetyl resin, wherein the flange includes titanium, and it is wherein described Flange prevents needle from being inserted into the substantive distance of the outer outlet body one.

The present invention discloses a kind of entrance port that is used to provide and subcutaneously enter to patient, described to include into port:Ontology, The ontology is defined through the enterable fluid cavity of spacer;Biddability outer outlet body, the biddability outer outlet body substantially cover The ontology is to limit the outer surface into port;And flange, the flange are covered by the outer outlet body and around institutes The periphery for stating ontology extends, and the flange includes by the visible identification division of X-ray imaging technique, and the identification division passes Information up at least one attribute into port indicates.

Wherein, the flange further includes the anchoring device that the outer outlet body is fixed to the ontology.

Wherein, the anchoring device and the identification division are integrated, and the wherein described flange is placed to prevent Needle is inserted into the substantive distance of the outer outlet body one.

Wherein, the flange usually limits a triangle, and the wherein described identification division includes being arranged described convex Alphanumeric tokens at the top of each of edge.

Wherein, the alphanumeric tokens are defined as the recess feature part in the flange, and wherein described convex Edge further includes the multiple through-holes for being defined through the flange.

Wherein, the identification division includes being defined through the mark of the flange, and wherein biddability plug is set It sets in the mark, to prevent the mark from the visible observation at least one direction.

Wherein, it is provided by the outer surface that the outer outlet body limits for applying the suitable surface of coating thereon, To prevent at least one of microorganism adhering and thrombosis.

The application discloses a kind of entrance port that is used to provide and subcutaneously enter to patient, described to include into port:Ontology, The ontology is defined through the enterable fluid cavity of spacer, and the ontology is limited by the following contents:Nasal portion, the nasal portion Including generally rigid material;And remainder, the remainder include compliance material.

Wherein, the remainder is overmolded on the ontology of the port and includes organosilicon, and The wherein described nasal portion includes thermoplastic material.

The application discloses a kind of entrance port that is used to provide and subcutaneously enter to patient, described to include into port:Ontology, The ontology is defined through the enterable fluid cavity of spacer;Biddability outer outlet body, the biddability outer outlet body is around the ontology At least part setting;And flange, the flange are covered by the outer outlet body and are extended from the ontology, the flange Including by the visible identification division of X-ray imaging technique, the identification division conveys at least one category into port Property information instruction, wherein at least part of the outer outlet body is so configured so that prevent the identification division to The visible observation in a few direction.

Wherein, the outer outlet body includes organosilicon, and at least part on the surface of the wherein described outer outlet body is texturing , it is opaque to make to be partly substantially described in the surface.

Wherein, the outer outlet body includes the organosilicon for being mixed with colorant, to make the organosilicon be opaque.

The application discloses a kind of manufacture for providing the method into port subcutaneously entered to patient, the method packet It includes:It is formed and is defined through the ontology of the enterable fluid cavity of spacer, the port body includes flange, and the flange is from neighbouring Radially, the flange includes anchoring device to the port body of the spacer;And extremely with biddability outer outlet body It is few to cover the flange in this way so that it includes the anchoring device on the flange that the outer outlet body, which is wrapped up in, by institute It states outer outlet body and is anchored to the ontology.

The manufacture further includes into the method for port:Coating is administered to the outer outlet body, the coating includes anti-micro- At least one of biology and antithrombus formation component.

Wherein, the step of at least covering the flange further includes most of cladding molding of the ontology around the port The outer outlet body, the outer outlet body include organosilicon.

Wherein, cladding moulds most of cladding mould that the step of outer outlet body further includes the ontology around the port Make the outer outlet body, at least part on the surface of the outer outlet body include the surface of texturing with prevent by the surface can Depending on observation.

The application discloses a kind of entrance port that is used to provide and subcutaneously enter to patient, described to include into port:Ontology, The ontology includes base portion and attachable lid, and the base portion and the attachable lid cooperation are defined through spacer can The fluid cavity of entrance;Biddability outer outlet body, the biddability outer outlet body are arranged around at least part of the ontology;And it is convex Edge, the flange are covered by the outer outlet body and are extended from the ontology, and the flange includes radiopaque material, described Flange is placed that needle is prevented to penetrate the substantive distance of the outer outlet body one.

Wherein, the flange include titanium and from the lid of the ontology radially.

These and other features of embodiment of the present invention will become from following explanation and appended claims It is more complete clear, or can be by being learned to the practice by embodiment of the present invention explained hereinafter.

The brief description of accompanying drawing

More specifical description to the present invention, the tool will be provided by reference to the specific embodiment of the present invention Body embodiment is illustrated in appended attached drawing.It is appreciated that these attached drawings only describe the typical embodiment party of the present invention Case, thus should not be construed as limiting the scope of the invention.It will be come by using Figure of description with additional feature and thin It saves and the exemplary implementation scheme of the present invention is described and is explained, wherein:

Figure 1A-Fig. 1 D are to enter port according to (overmolded) of the implantable cladding molding of an embodiment Various views;

The various views into port when over-mold point removes that Fig. 2A-Fig. 2 D are Figure 1A-Fig. 1 D;

Fig. 3 A- Fig. 3 E are the various views into port according to the implantable cladding molding of an embodiment;

Fig. 3 F are the bottom view into port body according to an embodiment;

Fig. 4 be and the top view for the port flange of Fig. 3 A- Fig. 3 E being used together into port;

Fig. 5 is the top view according to the port flange of an embodiment;

Fig. 6 A- Fig. 6 C are the various views according to the port flange and associated components of an embodiment;

Fig. 7 is the perspective view into port according to the implantable cladding molding of an embodiment;

Fig. 8 is the perspective view into port according to the implantable cladding molding of an embodiment;

Fig. 9 is the implantable sectional view into port for including identification division according to an embodiment;

Figure 10 is according to the saturating of the implantable body part into port including anchoring device of an embodiment View;

Figure 11 is according to the saturating of the implantable body part into port including anchoring device of an embodiment View;

Figure 12 is according to the saturating of the implantable body part into port including anchoring device of an embodiment View;

Figure 13 A- Figure 13 B be according to embodiment include the implantable into port of biddability body part Various views;And

Figure 14 A- Figure 14 B be according to embodiment include the implantable into each of port body of anchoring device Kind view.

The detailed description of selected embodiment

With reference to the drawings, wherein similar structure will be provided with similar Ref. No..It is appreciated that attached drawing is Graphic and signal the characterization of the exemplary implementation scheme of the present invention, and the attached drawing is unrestricted, need not also be pressed Ratio is drawn.

For clarity, it will be appreciated that, word " (proximal) of nearside " refers to opposite being wanted herein closer to using The direction of the clinician of the device of description, and word " (distal) in distal side " refers to the side for being relatively farther from clinician To.For example, the end for being placed on the conduit of patient's body is considered as the distal end portion of the conduit, and the conduit remains in External end is the proximal end of the conduit.In addition, the word as used in (including claims) herein " including (including) ", " with (has) " and " with (having) ", there should be same word " including (comprising) " phase The same meaning.

Figure 1A-Figure 14 B describe the various features of embodiment of the present invention, and embodiment of the present invention generally relates to be used for It provides and enters port to what patient body subcutaneously entered.Specifically, in one embodiment, it is implanted patient's body into port It is interior, then it is connect with the catheter fluid that has been inserted into patient's vascular system.It, can into port through such placement and configuration To be accessed percutaneously by needle or other infusion/suction units, thus by port and catheter drug delivery to patient's vascular system, or From the vascular system suction blood or other fluids of patient.

Include biddability outer outlet body into port in addition, in the embodiment to be described herein, the biddability outer cover Port is sutured or is otherwise secured to the enhancing of patient's body by patient comfort and offer when body increases implantation Option.In addition, in one embodiment, biddability outer outlet body includes bio-compatible materials (such as organosilicon), the biology Compatible material, which provides antimicrobial and/or antithrombus formation coating, can be applied to suitable surface thereon, to reduce Patient enters the risk or infection that port is brought by being implanted into.In one embodiment, include mark into the supplementary features of port Know part and anchoring device, which is used to be imaged the attribute of identification port by X-ray, which is used for will Outer outlet body is fixed to internal port ontology.

It shows usually to be noted as 10 according to an embodiment with reference first to Figure 1A-Fig. 2 D, Figure 1A-Fig. 2 D to plant What is entered enters the various views of port (" port ").As shown, port 10 includes limiting bottom surface 14 and the (figure of fluid cavity 20 Inside body 12 2A).The outer outlet body 16 discussed further below is set around ontology 12 substantially to cover ontology 12, removes It the opening 22 of fluid cavity 20 and is placed in the opening and penetrates spacer 24 with cover the fluid cavity.

More specifically, being existed by maintenance ring (retaining ring) 26 in embodiment illustrated spacers 24 It is maintained on appropriate location in the opening 22 of fluid cavity 20, maintenance ring 26, which is inserted into opening 22, to be come with tight fit (interference fit) engages port body 12.As best visible in fig. 1 c, outer outlet body 16 covers the sheet of port 10 The surface of body 12 reaches (up to) around the border circular areas of maintenance ring 26.In addition to the content being explicitly illustrated in the accompanying drawings, outer outlet body can To include other configurations.

In the present embodiment, the ontology 12 of port 10 includes titanium or other suitable metal materials.It to be described herein Other embodiments in, port body includes nonmetallic materials.The additional detail of port 10 include it is multiple touch by part 28 and with The fluid outlet 30 that fluid cavity 20 is in fluid communication, the multiple touch is included in by part 28 on the top surface of spacer 28, in skin The identification of auxiliary port after lower placement.The guide rod (stem) 32 for limiting a pipeline (conduit) is fixedly received in fluid In outlet 30, to provide fluid channel between fluid cavity 20 and the conduit for being attached to guide rod.

As mentioned, outer outlet body 16 includes compliance material and covers port body 12.In one embodiment, outside Cover body 16 includes organosilicon, the bio-compatible materials of the A types Shore hardness (30Shore A durometer) with 30, so And it is understood that the biology that other can also be used suitable is compatible and is obedient to material (including thermoplastic elastomer).Due to it It is obedient to property, outer outlet body 16 provides increased comfort level when being implanted patient's body for it.In addition, outer outlet body 16 is can by needle It is piercing through so that be all firm by the suture of a large amount of positions on the outer outlet body, port is fixed to patient to provide Internal convenience.

In addition, in one embodiment, biddability outer outlet body 16 provides application for the one or more of component 10 The suitable surface of coating.This is strictly so in some cases, for example, including titanium or other metals in port body 12 Or with DELRINTMName sell acetyl resin (acetyl resin) in the case of, coating is usually relatively difficult to attached These materials.

In an exemplary embodiment, antimicrobial and/or antithrombus formation coating (one or more) can be by Be administered to the surface of outer outlet body 16, with prevent on port 10 or 10 surrounding growth bacterium of port and/or formed thrombus.It can be by The non-limiting examples for being administered to the coating of the outer outlet body 16 of port 10 may refer to the following contents:August is submitted on the 1st within 2005 , the U.S. Patent application of entitled " antimicrobial silver components (Antimicrobial Silver Compositions) " it is public Open No.2007/0003603;On 2 8th, the 2007 " methods on the surface for metallic nanoparticle subprocessing submitting, entitled With component (Methods and Compositions for Metal Nanoparticle Treated Surfaces) " U.S. The open No.2007/0207335 of state's application;And " antimicrobial position dressing submitting, entitled on April 25th, 2007 The U. S. application of (Antimicrobial Site Dressings) " discloses No.2007/0293800.Further coating example It may refer to the following contents:It is entitled " to form method (the Method of Making Anti- on anti-microbial polymer surface Microbial Polymeric Surfaces) " United States Patent (USP) No.6,808,738, it is entitled " to pass through therapeutic type hydrogel Drug delivery (Drug Delivery via Therapeutic Hydrogels) " United States Patent (USP) No.6,475,516, with And on 2 26th, 2002 " method (the Method of Making on formation anti-microbial polymer surface submitting, entitled Anti-Microbial Polymeric Surfaces) " U.S. Patent application No.2004/0086568.Aforementioned patent and Shen Please each of by quote and be integrally incorporated herein.Can also use those skilled in the art will appreciate that other cover Layer.

In one embodiment, the antimicrobial coating for being administered to outer outlet body includes silver and further includes preventing outer outlet body The component obviously to change colour, for example, commonly known as brilliant green CAS 633-03-4 (Brilliant Green, CAS Number633-03-4 stain component).In another embodiment again, antimicrobial, antithrombus formation or other are suitable Material can be added to outer outlet body material, and be configured to come from outer outlet body material elution (elute) with desired rate Desired property is provided for the surface of outer outlet body.In one embodiment, outer outlet body can be colored to fall into be based onMatching system (Matching System) (Pantone in the New Jersey cities karr Shi Date is public Department) specific color gamut, such as Pantone 3272M and similar color (proximate colors).

It is noted that the ontology 12 and maintenance ring 26 of the port 10 shown in the present embodiment of Figure 1A-Fig. 2 D include Titanium.In the certain embodiments being described below, other materials is used for port body.It is remembered that in addition to this paper institutes Except disclosure, other suitable materials can also be used for the various components of port without departing from reality described herein Apply the spirit of scheme.

According to an embodiment, port 10 further includes the flange of the periphery of the ontology 12 around the port radially 40.As best visible in fig. ib, flange 40 is around the opening 22 of spacer 24 and fluid cavity 20 and 24 He of adjacent partition part The opening 22 of fluid cavity 20 is circumferentially disposed.It is configured in this wise, flange 40 is used as needle gear guard (needle guard), uses In prevent needle or other infusion/suction units penetrate 16 relatively close port 10 of outer outlet body spacer 24 part.So again It prevents the user of needle from penetrating biddability outer outlet body 16 and it is therefore believed that the needle comes into spacer 24, spacer 24 is one Also include compliance material, such as organosilicon in a embodiment.In this case, flange 40 will prevent user from wearing needle Enter outer outlet body, this will be prompted to user and needs needle thus being avoided further problem again insertable into enter spacer 24.It wants Understand, in the present embodiment, flange is integrally formed with port body and thus includes titanium.However, in other realities It applies in scheme, flange can be manufactured separately, and may include other suitable materials, can be prolonged from other regions of port body Stretch rather than the place of adjacent partition part, and may include different shape and configuration.

In one embodiment, flange 40 is also used for the knowledge of the enable port in a manner of including special characteristic or attribute Not.For example, flange 40 may include by X-ray or the visible one or more mark parts of other similar imaging techniques Point, to the identification of the enable port respective attributes after port is implanted into the patient.It can be identified the attribute of part instruction An example to be port carried out wherein with relatively high flow velocity (commonly known as power injection) fluid infusion ability.This The power of sample can injection be useful, for example, when by being imaged with the computerized tomography (" CT ") carried out to patient body When contrast medium is injected in the port 10 that journey is used in combination.In one embodiment, by the power of port injection stream with per second about zero It is carried out to five milliliters of rates, however this can change according to a number of factors.

According to the above, in one embodiment, port flange 40 is included in Fig. 1 C, Fig. 1 D and Fig. 2 D most preferably Visible one or more identification divisions 50.Specifically, the identification division 50 of the present embodiment includes being limited at flange 40 Ontology in alphanumeric tokens 52.In more detail, the flange 40 in the present embodiment includes that one group of three alphanumeric is remembered Numbers 52, wherein each mark includes the letter " CT " for being defined through the thickness of flange, to port by X-ray by As when the holes CT of flange and around radial imaging contrast is provided between ontology.The orientation of " CT " letter is such, so that It will indicate whether port is positioned properly and orients in patient's body in its observation under X-ray.

Consider, identification division 50 described above can be one or more alphanumeric characters, such as Figure 1A- " CT " described in Fig. 2 D.In addition, the disclosure considers on flange using other labels, such as one or more symbols, figure Case, character, design and combinations thereof etc..Identification division (one or more) can be any size, shape or be any ruler Both very little and shapes, one or more specific identifications in each attribute to enter port for this customize the mark Part.Specifically, in one embodiment, as already discussed, identification division (one or more) can be conveyed to operator About the port being implanted into power can injection information.Other examples for the attribute that identification division can be conveyed include port Type, catheter type, date of manufacture, batches of materials, dash number etc..In other embodiments, identification division can be with it His mode limits.

In one embodiment, flange 40 also acts as another effect, that is, is used for fixed port ontology 12 and outer outlet body The anchoring device of engagement between 16.As described above, in the present embodiment, alphanumeric tokens (" CT ") 52 are defined as By the hole of 40 thickness of flange, the inside body 12 of the flange and port 10 together by including.During the manufacture of port 10, outside Cover body 16 wraps up in packet port body 12 by over-mold process, and wherein organosilicon or other suitable flowable materials is injected Include the mold of port body 12, to which organosilicon wraps up in the major part of the packet port body, including flange 40.Then, organosilicon It is allowed to cure to form outer outlet body 16.During over-mold process, flowable organosilicon flows through the hole of CT marks 52 simultaneously And be held in the hole after solidification is completed, to limit combination of the holes the CT neutralization by the holes CT by organosilicon, by Outer outlet body 16 is anchored to port body 12 as single component and prevents separation therebetween by this.

Such as below will be further visible, anchoring device as described herein can be from shown in Figure 1A-Fig. 2 D Appearance is changed.In one embodiment, adhesive can be used to outer outlet body 16 being adhered to port body 12, especially exist Outer outlet body is near the rounded ends of port body openings 22.Bonding outer outlet body can be used for preventing from being administered in this region Any coating or layer of the outer surface of the outer outlet body ooze out under outer outlet body 16.The example of suitable adhesive is from Jia Lifu NuSil technologies Co., Ltd (the NuSil Technology LLC of in Buddhist nun Asia state card flat trie Asia city Carpinteria, CA) it is obtainable.

It is best visible such as in Fig. 1 D, in one embodiment, before cladding moulds outer outlet body, including with outer cover The insertion body 56 of 16 identical material of body is attached to the bottom surface 14 of internal port ontology 12.The purpose of insertion body 56 is, at this Before outer outlet body is overmolded on the ontology, help to stablize internal port ontology 12 and fix in a mold.At one In embodiment, both outer outlet body 16 and insertion body 56 all include organosilicon, to whole during over-mold process both It is combined.In the another embodiment shown in Fig. 3 F, including the disk 70 of suitable radiopaque material (such as titanium) can The insertion body 56 on bottom surface 14 to substitute internal port ontology 12 and may include by the mutual of X-ray imaging device Visible identification division 50 is acted on, so that the feature of the port or attribute are can be identified after the implants.It is said in diagram In bright embodiment, disk includes the alphanumeric shape cutaway portion (cutout) of alphabetical " CT ".

Fig. 3 A- Fig. 3 E describe the various views of the port 10 according to another embodiment, the inside body 12 of middle port Including thermoplastic, such as usually with DELRINTMName sell acetyl resin.As best visible in figure 3b, end Mouth ontology 12 passes through ultrasonic bonding or other suitable technique quilts including base portion 12A and lid 12B, base portion 12A and lid 12B With being connected together to limit fluid cavity 20 and spacer 24 is locked (capture) therebetween.In this way, not as Figure 1A-figure The metal port of the previous example of 2D uses maintenance ring like that.

The port 10 of Fig. 3 A- Fig. 3 E includes the flange as the separately manufactured component for the ontology 12 for being attached to port 10 40.Specifically, and referring also to Fig. 4, the flange 40 of the present embodiment includes centre bore 40A, so that flange can receive end Mouthful ontology 12 is by wherein and as best visible in Fig. 3 B and Fig. 3 C, positioned at the boss being limited on lid 12B (ledge) top.Multiple recesses 60, which are defined and are corresponded to around the periphery of the centre bore 40A of flange 40, is included in lid The tongue 62 of multiple extensions on the boss of 12B.Recess 60 and corresponding tongue 62 are combined with key-shaped relative to each other (keyed), to enable flange 40 to be only located in being properly oriented at the top of boss, that is to say, that, it is ensured that alphanumeric is remembered It number is placed in and to be properly oriented within relative to port.

In the present embodiment, it has appropriately been placed on lid 12B in flange 40 during being manufactured shown in Fig. 3 C Later, recess 60 will be located on the tongue 62 of lid.Tongue 62 may then pass through fusing, machinery or other suitable deformation works Skill is deformed, on lid 12B and prevent it from being removed from lid 12B the locking of flange 40.

As mentioned, Fig. 4 shows the other details of flange 40, includes the alphanumeric tokens of each identification division 50 52, centre bore 40A and recess 60.It is noted that in the present embodiment, flange includes the outer peripheral edge one of titanium and flange 40 As limit (bulged) triangle of protrusion, wherein being mounted with phase in alphanumeric tokens 52 at each top of the triangle One answered, the mark play the role of identification division and by outer outlet body 16 be fixed to port body 12 anchoring device the two. In one embodiment, " CT " mark 52 is formed on by line EDM cutting in flange 40, however can also can using other Method of receiving, including punching press, molding etc..It is to be understood that size, shape and the component of flange and the structure of identification division It can be different from content illustrated and described herein.For example, other suitable materials that flange may include may refer to On June 8th, 2010 is submitting, entitled " to identify system and method (the Systems and into port in a manner of radial imaging Methods for Radiographically Identifying an Access Port) " co-pending United States Patent (USP) Apply No.12/796,133, this application by reference be integrally incorporated herein.

Fig. 5-9 shows the details of the additional embodiment about flange 40.Fig. 5 shows flange according to an embodiment 40, wherein identification division 50 (being represented as alphanumeric tokens 52 herein) is not defined through the whole thickness of flange, and It is only defined the thickness partially across flange, to form the feature of recess.In one embodiment, mark 52 is defined For, with about 0.015 inch of depth, the overall thickness which includes is about 0.020 inch, however other depths in flange 40 Degree and thickness of flange are also possible.This makes " CT " mark 52 (before implantation) only watch end with visual angle from top to bottom It is visually visual, such as visual angle shown in Fig. 1 C and Fig. 3 D when mouthfuls 10.In addition, CT marks formed in this way 52 provide the comparison of sufficient radial imagings so that mark can after port is implanted by X-ray imaging can by Thus picture plays the role of the identification division needed for port 10.Mark 52 can be by line EDM processing, laser-induced thermal etching etc. come shape At.In addition, multiple through-holes 76 are defined through the thickness of flange 40, for use as the anchoring device of flange.Flange 40 with Figure 1A- Similar mode is placed shown in Fig. 3 E.

It is noted that in embodiment above and the selected embodiment to be followed, port attribute for identification Identification division be so configured so that their (for example, before implantation) are only visually from predetermined visual angle Visual, such as the visual angle shown in Fig. 5 from top to bottom.In one embodiment, this restriction visual angle of identification division Vision viewing be useful, to indicate the top of clinician port;That is, when port is placed upward by top When, identification division is visually can be identified, indicates appropriate orientation, the body for port to be inserted into patient.So And when port is to be squeezed, identification division is visually sightless, thereby indicates that the clinician port is to be squeezed 's.This feature is it is possible thereby to for eliminating the puzzlement that clinician is appropriately oriented about port.Furthermore, it is to be understood that one In a embodiment, all or part of the outer outlet body of port can be made into opaque, will be convex to eliminate clinician The CT mark cutaway portions of edge be mistakenly considered suture by by sewing hole possibility.

Fig. 6 A- Fig. 6 C show each of the flange 40 according to another embodiment, " CT " alphanumeric tokens 52 therein It is used as identification division 50, is somebody's turn to do " CT " alphanumeric tokens 52 and is defined as by thickness of flange such as previous example Cutaway portion.Limit the opaque triangle plug of biddability of the protuberance embossment alphabetical " CT " corresponding to " CT " of each mark 52 80 are inserted into " CT " cutaway portion of each mark, and thus by maintenance.Through disposing in this way, plug makes " CT " mark 52 (before implantation) only when watching port 10 with visual angle from top to bottom it is visually visual, such as in Fig. 1 C and Fig. 3 D Shown in visual angle.When visually being watched from port bottom, plug prevents respective mark 52 from being observed.On the contrary, plug The shape (being triangle in the present embodiment) of bottom is visible.It is noted that the shape of plug can change, plug Protuberance embossment on top surface can also change, to design the cutaway portion for the mark being inserted into corresponding to plug.

Fig. 7 shows port 10 according to an embodiment, and the outer outlet body 16 of middle port includes texturing surface (frosted surface) 84 or the surface (obscured) being otherwise blurred, so that the outer outlet body is not Transparent.In one embodiment, the texturing surface 16 of port 10 is realized during coating moulding phases, wherein for will be outer The surface that cover body 16 is overmolded into the mold of internal port ontology 12 includes the bead (bead for example by die surface Blasting) the rough surface obtained.When outer outlet body 16 is overmolded with such mold, the texturing surface of Fig. 7 is obtained 84.It is to be understood that the method that other can also be used suitable provides texturing surface or opaque surface for outer outlet body 16. Again in another embodiment, the bottom surface of only outer outlet body is texturing.

In another embodiment, fabric or reticular structure can be incorporated into/be embedded in the outer outlet body of port, to make it be Opaque.It is not bead, abrasive surface can be processed to limit diamond on it in another embodiment again Meshy surface feature, this will assign the port outer outlet body coarse opaque surface when port outer outlet body is overmolded to wherein. Again in another embodiment, logo (logo) or other features can be carved into the port outer outlet body, or as the outer outlet body It is overmolded into the surface characteristics of the die surface of port body wherein by including so that the outer outlet body is at least partly Ground is opaque.Thus, it can be assumed that these and other processing for making outer outlet body opacity.

Fig. 8 shows port 10 according to an embodiment, wherein colorant or other suitable opaque additives with The material (for example, organosilicon) of outer outlet body 16 is used to form together by including so that outer outlet body is opaque.At one In embodiment, such as by Kreative fluid pigments company (the Kreative Liquid in California Ontario Color of Ontario, CA) provide Kreative purples K-6050-13 (Kreative Color Purple, K-6050- 13) colorant mixes before over-mold process with organosilicon, and the opaque of port 10 is obtained after cladding molding is completed Outer outlet body 16.It is, of course, also possible to using other materials and method come so that outer outlet body to be opaque.In an embodiment In, the required feature of colorant or opaque additive include translucent ray, bio-compatibility and with form outer outlet body Material compatibility.

Fig. 9 shows the port 10 according to another embodiment, wherein other than flange 40, as shown in Figure 9, the second plate 90 are placed under flange.As flange 40, plate 90 is covered by outer outlet body 16 and includes in one embodiment Through-hole is used as ensuring the anchoring device of the engagement between outer outlet body 16 and the inside body 12 of port 10.Equally it is and flange 40 The same, plate 90 may include titanium, bismuth oxide or other suitable materials, or can be different from flange in component 40.As illustrated in fig. 9, the placement of plate 90 will act as the mark of the identification division of flange 40 visual observation be limited to such as Fig. 1 C and Viewing from top to bottom in Fig. 3 D.

Figure 10-Figure 12 describes various embodiments, and the anchoring device of the open inside body 12 for port 10 adds Embodiment.The anchoring device to be described will coat molding outer outlet body be fixed to internal port ontology when, with reality above Apply " CT " mark cutaway portion and the operation of other anchoring device similar modes of the flange 40 described in scheme.

In Fig. 10, anchoring device 130 is included on the flange 140 of port body 12.Flange 140 is around being included in port Spacer 24 and adjacent partition part 24 on ontology 12 are circumferentially disposed.Specifically, anchoring device is implemented as being defined Pass through multiple through-holes 142 of flange 140.In addition, at 140 times abundant distances of flange, one or more convex extension parts 146 from Port body 12 extends to limit additional through-hole 148.Such as have been combined this paper the embodiment including anchoring device and Described in other embodiments, be used to form outer outlet body organosilicon or other suitable materials during over-mold process Inside body 12 around port flows, and reinforces attachment of the outer outlet body to port body in line with expectations by anchoring device 130.

Figure 11 shows another embodiment of the anchoring device 130 of port body 12, wherein at the bottom of neighbouring port body 12 Annular groove 150 is limited at portion 14.Multiple through-holes 152 are defined in this slot to extend to port body bottom surface 14 from the slot, So that outer outlet body material can flow through wherein during over-mold process.

Figure 12 describes the still another embodiment of anchoring device 130, and plurality of tooth 160 prolongs from the surface of port body 12 It stretches.Specifically, in fig. 12, opposite tooth is shown to extend towards one another to (pairs of teeth) 160, not only opposite Tooth between gap is provided, and also gap is provided between tooth and the adjacent side of port body 12, to provide outer outlet body The suitable space that material can flow through before being solidified after outer outlet body to be anchored to port body in cladding molding.The ruler of tooth Very little, shape, number and position can change in many ways.More generally, it is to be understood that the embodiment of front is only The embodiment of anchoring device may exist the other types and structure of anchoring device in the principle of embodiment of the present invention.

Figure 13 A and Figure 13 B describe port 210 according to an embodiment, and the ontology 212 of middle port includes first Body portion 212A and the second body part 212B, the first noumenon part 212A limit the nose of ontology, second body part 212B limits the remainder of ontology.In the present embodiment, the first noumenon part 212A include the biology of relative stiffness can be simultaneous Capacity materials, such as acetyl resin or other thermoplastics, and the second body part 212B includes compliance overmolded material, example Such as organosilicon or other suitable bio-compatible materials.It is configured so that, the port sheet limited by the first noumenon part 212A Body nose is relative stiffness, to contribute to port to be put into bag-like region defined by the tissue of patient (pocket), and by The remainder for the port body 212 that two body part 212B are limited is biddability, to increase the comfort level of patient and carry The suture property of high port 210.The cladding molding of second body part can be with real with previous embodiment similar mode It is existing.

Figure 14 A and Figure 14 B describe the still another embodiment of anchoring device 130, and plurality of dovetail (dovetail) is convex Extending portion 220 extends from the round sides of port body lid 12B around its periphery.Dovetail convex extension part 220 is in adjacent dovetail Between provide outer outlet body material cladding molding with outer outlet body is anchored to after port body solidify before the foot that can flow through Enough surface areas and the region delay (entrapment).The size of wedge-shaped tenon tooth, shape, number, position and interval can be with Change in many ways.For example, other than being included on the lid of port, these dovetail convex extension parts can be included in end On mouth base portion.Meanwhile although showing that the entirety around port lid periphery extends, in one embodiment, dovetail protrudes out Portion can be defined as extending only partially around at this.Consider these and other versions.

Embodiment of the present invention can be implemented in the form of other are specific, without departing from the spirit of the present invention.It is described Embodiment should be considered as in all respects all only as illustrative and not restrictive.Thus, the present invention is real The range of scheme is applied shown by appended claims rather than aforementioned specification.Meaning in claims and equal homotypes All changes in enclosing are intended to be included in the scope of the present invention.

Claims (18)

1. what a kind of power can inject enters port, what the power can inject includes into port:
Ontology, the ontology are defined through the enterable fluid cavity of spacer;
The spacer is limited in described of the fluid cavity nearside by continuous annular flange, the continuous annular flange The top of body, the flange are formed by radiopaque material, and the flange includes one or more identification divisions, and described one A or more identification division conveys what the power can inject can be injected into port into action edge to user;With And
Biddability outer outlet body, the outer outlet body be set around the ontology and with the Hp contacts.
2. what power as described in claim 1 can inject enters port, wherein the flange and the ontology are by integrated landform At.
3. what power as claimed in claim 2 can inject enters port, wherein the flange and ontology are formed by titanium material.
4. what power as described in claim 1 can inject enters port, wherein the flange includes for by the outer outlet body One or more openings fixed to the ontology.
5. what power as claimed in claim 4 can inject enters port, wherein one or more opening is formed One or more identification division.
6. power as described in claim 1 can inject enter port, wherein one or more identification division be by Be formed as alphanumeric or the opening of significant character.
What 7. power as described in claim 1 can inject enters port, wherein the ontology includes lid and base portion, it is described convex Edge is placed at the top of the lid.
8. what power as claimed in claim 7 can inject enters port, wherein the biddability outer outlet body substantially covers institute Lid and the base portion are stated to limit the outer surface into port.
9. what power as described in claim 1 can inject enters port, wherein the ontology includes extending from the ontology One in multiple teeth and multiple dovetail convex extension parts.
10. what power as described in claim 1 can inject enters port, wherein the outer outlet body includes antimicrobial components And/or antithrombus formation component.
11. what power as described in claim 1 can inject enters port, wherein the ontology is formed by the first material and institute Flange is stated by being formed different from the second material of first material, and the wherein described flange separated with the ontology and by It is attached to the ontology.
12. what power as claimed in claim 11 can inject enters port, wherein the flange includes multiple key-shaped recesses, often A key-shaped recess is assembled on the corresponding key-shaped tongue on the ontology, and the wherein described tongue can be set in the recess It is deformed in this way after on the tongue, so that the flange is by the ontology maintenance.
13. what power as claimed in claim 12 can inject enters port, wherein the ontology of the upstream end mouth includes Acetyl resin, and the wherein described flange includes titanium.
What 14. power as described in claim 1 can inject enters port, wherein the flange limits triangle, and wherein One or more identification division includes the alphanumeric tokens being arranged at the top of each of described flange.
15. what power as claimed in claim 14 can inject enters port, wherein the alphanumeric tokens are defined as institute The recess feature part in flange is stated, and the wherein described flange further includes the multiple openings for being defined through the flange.
16. what power as described in claim 1 can inject enters port, wherein the biddability outer outlet body is provided for applying The suitable surface of coating thereon, to prevent at least one of microorganism adhering and thrombosis.
What 17. power as described in claim 1 can inject enters port, wherein the biddability outer outlet body includes organosilicon, And at least part on the surface of the wherein described biddability outer outlet body is texturing, to make the part base on the surface It is opaque in sheet.
18. what power as claimed in claim 17 can inject enters port, wherein the outer outlet body includes being mixed with colorant Organosilicon, to make the organosilicon be it is opaque.
CN201510645219.1A 2009-11-17 2010-11-01 Cladding molding including anchoring device and identification division enters port CN105288836B (en)

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US61/262,126 2009-11-17
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